Behandling af Boern Med Foedevareallergi Med Omalizumab (... | NCT04037176

Studies
Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

NCT04037176

Sponsor

Carsten Bindslev-Jensen

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

20Actual

Phase

Phase 4

Conditions

Food Allergy

Interventions

Omalizumab
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

May 10, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 5, 2023Actual

Name	Class
Novartis Pharmaceuticals	INDUSTRY
Thermo Fisher Scientific, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.

Detailed Description

Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy.

Primary endpoint: Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.

Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)), severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold within and between the groups.

The investigator's hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold.

Within the groups:

3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose - in primary responders
3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose - in primary non-responders
3 months treatment with placebo versus 6 months with placebo- in primary placebo-responders
3 months treatment with placebo versus 3 months with max dose Omalizumab - placebo cross over to active.

Between the groups:

3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab
6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab.

Patients are randomized electronically via an e-CRF prepared by OPEN in RedCap. Assigned 3:1 to Omalizumab or placebo in 13 x 8 block (6:2) by a blinded health care person.

GCP-monitoring is performed by the local GCP-unit at Odense University Hospital

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omalizumab	Active Comparator	Omalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab. 75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously	Drug: Omalizumab
Placebo	Placebo Comparator	Placebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection. 25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders. Placebo is administered subcutaneously	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE	Omalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in challenge threshold (mg food protein tolerated by oral intake)	Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo	0-3 months

Secondary Outcomes

Measure	Description	Time Frame
Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))	To estimate improvement in QoL before and after 3 months and 6 months treatment, using FAQLQ on a seven point scale with one as the best possible score (score 1-7)	0-6 months
Change in skin prick test size (mm)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children between 6 and 18 years
a clinical diagnosis of food allergy to ≥1 food allergen
a positive SPT (mean wheal diameter > 3 mm)
s-IgE > 0.35 kIU/l
a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC).
(If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of s-IgE and when available challenge results within the last year) will be used).

Exclusion Criteria:

t-IgE >1500 kIU/L.
Significant co-morbidity that might compromise the patient's safety or study outcomes.
Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken.
Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
Alcohol abuse, abuse of opioids or other drugs in adolescents
Treated with Omalizumab until ½ years before the study
Patients/parents who are not supposed to be able to meet the requirements in the protocol
Patients/parents who are physically or mentally unable to consent
Patients who have reduced liver function or kidney function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carsten Bindslev-Jensen, Prof DM PhD	Odense Research Center For Anaphylaxis	Study Director
Susanne Halken, Prof DM MD	Department of Childrens Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense Research Center for Anaphylaxis, Allergy Center, Odense University Hospital		Odense C	Funen	5000	Denmark

ID	Term
D005512	Food Hypersensitivity

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000069444	Omalizumab

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Intervention Model Description

Eligible participants will be randomized to treatment with Omalizumab (regular dose of asthma dosing according to total IgE and weight) or placebo (3:1). Primary endpoint after 3 months treatment.

Responders (in the active as well as the placebo group) will continue treatment with the same dose of Omalizumab/placebo for a further 3 months. All non-responders will receive maximum dose of Omalizumab (according to weight, but not total IgE) for another 3 months.